510(k) Report

510(k) · Cleared

Cleared

Restoration Anatomic Shell

K142462510(k) TraditionalCleared Nov 14, 201473-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Orthopaedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Nov 14, 2014 as substantially equivalent to K010170 (Howmedica Osteonics Corp., 2001) and 1 other predicate after a 73-day review. Its family tree reaches back 1 generation to 1991. 19 later devices descend from it.

Decided
Nov 14, 2014
Review
73 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K905258 (1991). 2 ancestors in all. 19 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2016: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant cleared2019: 2 descendants cleared2022: 4 descendants cleared2020: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared2025: 4 descendants cleared2024: 2 descendants clearedK905258 · S-Rom Oblong Acetabular Cup · Joint Medical Products Corp. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 8 descendants3 generations forward: 9 descendants K905258 · S-Rom Oblong Acetabular Cup · Joint Medical Products Corp. · 19910
  1. Root · 1 generation backK905258 S-Rom Oblong Acetabular CupJoint Medical Products Corp. · 1991
  2. This deviceK142462 Restoration Anatomic ShellStryker Orthopaedics · 2014
  3. Descendant · cites it directly · 18 of its ownK151264 Restoration Anatomic ShellStryker Orthopaedics · 2015 · Recalled
  4. Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
  5. Descendant · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
  6. Descendant · 2 generations on · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
  7. Descendant · 2 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12018: 12019: 22020: 12021: 12022: 42023: 12024: 22025: 42026: 1
2015high 4 (2022) · low 0 (2017)2026

Most influential descendants

Showing 5 of 19 · See all
  • K151264Restoration Anatomic ShellStryker Orthopaedics · 2015 · cites it directly18descendants
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 2 generations on8descendants
  • K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 2 generations on7descendants
  • K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K905258S-Rom Oblong Acetabular CupJoint Medical Products Corp.1991—
0 (this device)K142462Restoration Anatomic ShellStryker Orthopaedics2014—
+1K151264Restoration Anatomic ShellStryker Orthopaedics201517
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics20161
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics20182
+2K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2019—
+2K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201810
201920
202010
202110
202240
202310
202420
202540
202610
FIG. 1 — Lineage of K142462, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K010170Trident Porous Titanium Acetabular Component
Summary page 4
…hesis. (888.3358) Product Codes: LPH Legally Marketed Device to Which Substantial Equivalence is claimed: x Trident Porous Titanium Acetabular Shell (K010170) x S-ROM Oblong Cup (K905258) Device Description: The Restoration Anatomic Shell is intended for cementless fixation into…
Howmedica Osteonics Corp.2001—
*K905258S-Rom Oblong Acetabular Cup
Summary page 4
…LPH Legally Marketed Device to Which Substantial Equivalence is claimed: x Trident Porous Titanium Acetabular Shell (K010170) x S-ROM Oblong Cup (K905258) Device Description: The Restoration Anatomic Shell is intended for cementless fixation into a prepared acetabulum for either p…
Joint Medical Products Corp.1991—

Also cleared against K010170: 8 other devices →

What descends from it? (19)

See all 19

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151264Restoration Anatomic ShellStryker Orthopaedics201518
K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics201617

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K151264 (Stryker Orthopaedics, 2015) has gone furthest, with 18 descendants of its own.
  • 8 other devices also cite its predicate K010170.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.

Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.

Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

The Restoration® Anatomic Shell is indicated for cementless use only.

Indications for use as stated in the FDA summary.

Also cleared against K010170

8 other devices cite the same predicate.

  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 20161 recall
  • K151264Restoration Anatomic ShellStryker Orthopaedics · 201517 recalls
  • K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct…Stryker Orthopaedics · 20152 recalls
  • K112802Pipeline Total Hip SystemPipeline Orthopedics · 2012
  • K103233Modular Dual Mobility Liner, X3 Acetabular InsertHowmedica Osteonics Corp. · 20111 recall
  • K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp. · 2008

More from Stryker Orthopaedics

24 FDA decisions under this applicant name. See the company

  • K211703Insignia Hip StemStryker Orthopaedics · 2021
  • K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 20182 recalls
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 20183 recalls
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 20171 recall

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K142462 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142462: Restoration Anatomic Shell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142462

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026